NCT02285777

Brief Summary

This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102\_16 study will be invited at the time of their last study visit to participate in this extension study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 6, 2017

Completed
Last Updated

September 24, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

November 5, 2014

Results QC Date

September 6, 2017

Last Update Submit

August 22, 2018

Conditions

Meningococcal Disease

Outcome Measures

Primary Outcomes (1)

  • Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.

    The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.

    At Month 7 (1 month after the 3-dose vaccination series)

Secondary Outcomes (23)

  • Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.

    At Month 10 (4 months after the 3-dose vaccination series)

  • Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.

    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

  • Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series

    At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

  • Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series

    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

  • HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

  • +18 more secondary outcomes

Study Arms (2)

MenABCWY Group

EXPERIMENTAL

Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.

Biological: Meningococcal ABCWY

MenACWY Group

ACTIVE COMPARATOR

Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.

Biological: Placebo

Interventions

Meningococcal ABCWYBIOLOGICAL

One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

MenABCWY Group
PlaceboBIOLOGICAL

One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

MenACWY Group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).

You may not qualify if:

  • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
  • History of any meningococcal vaccine administration other than vaccination given in the parent V102\_16 protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Investigational Site

Huntsville, Alabama, 35802, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Melbourne, Florida, 32934, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40207, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

Related Publications (2)

  • Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.

    PMID: 35257644DERIVED

  • Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.

    PMID: 30061029DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

December 1, 2014

Primary Completion

March 26, 2015

Study Completion

June 11, 2015

Last Updated

September 24, 2018

Results First Posted

December 6, 2017

Record last verified: 2018-05

Locations

US(8)